• Clinical Trials Evolve: Mixed FSP/FSO Models Add Agility and Expertise

    Dec 19 | Clinical Research News | For every day of delay in a clinical trial, sponsors lose $500,000 in prescription drug sales and incur $40,000 in direct clinical trial costs, according to the Tufts Center for the Study of Drug Development. These numbers show why speed and control matter more than ever, as drug development continues getting more complex and expensive. More

  • Six 2025 Site Innovation Award Finalists Named

    Dec 18 | Clinical Research News | The 3rd Annual Site Innovation Award has just named finalists for 2026, recognizing sites and partnerships pioneering new approaches to improving clinical trials. Finalists will present their concepts in-person at SCOPE, February 3-6, 2025, in Orlando, Fla, and winners will be named during the event. More

  • An Expert’s Insight on Women’s Health Research Facing Setbacks

    Dec 17 | Clinical Research News | Progress toward equitable representation of women in clinical research—formally recognized only in 1993 when the FDA directed sponsors to include women in clinical trials—has stalled, and recent federal actions may be widening long-standing scientific blind spots. The consequences reverberate through decades of drug approvals, safety failures, and missed opportunities for understanding biological differences critical to therapeutic innovation. More

  • Psychedelic Therapies Enter a Crucial Phase as Clinical Research Accelerates

    Dec 16 | Clinical Research News | As psychedelic and dissociative-based medications pick up more interest, they may enter mainstream psychiatry in the coming years. Though ketamine and psilocybin are highlighted for their potential, their mechanisms—and side effects—still require further investigation. More

  • 2026 Participant Engagement Award Finalists Address Pediatric Patients; Lupus; Vaccine Trials; Recruitment Issues

    Dec 11 | Clinical Research News | Finalists have been announced in the 10th annual Participant Engagement Awards. Four projects from Biogen, Proximity Health Solutions, and BlackDoctor.org; Empath Labs; PACT; and Science 37 and RxE2 will be presented during a live judging session at SCOPE in Orlando, Florida, Feb 2-5, 2026. More

  • The Scope of Things: Practical Regulations Strategies for Clinical Efficiency

    Dec 09 | Clinical Research News | The FDA’s decades-old regulation 21 CFR Part 11—which establishes criteria for electronic records and signatures to be considered trustworthy and equivalent to paper records—is in dire need of an update. Doug Bain, founder and consulting partner of ClinFlo, has his own proposal on reformations to streamline clinical trials and improve experiences for patients, sites, and sponsors, which he discusses extensively in this month’s episode of the Scope of Things. More

  • Statistical Considerations in Decentralized Clinical Trials

    Dec 05 | Clinical Research News | Decentralized clinical trials (DCTs) aim to harness the power of technology to lower the burden of clinical trial participation, increase engagement and improve outreach and diversity. However, for these benefits to be realized, we need to understand the specific challenges created by DCTs and how to mitigate them. More

  • Next-Generation Immunotherapy Nears the Clinic with Dual Cancer Trials

    Dec 03 | Clinical Research News | Glycans are the complex sugar chains found at abnormally high levels on the surface of cancer cells—and one of the toughest challenges in cancer treatment. A research team from the UC Irvine School of Medicine developed glycan-dependent T cell recruiters (GlyTRs), which represent a first-of-its-kind approach that bypasses traditional antibody mechanisms to attack cancer’s sugar-coated armor. More

  • Space Health Research Could Rack Up Many Earthly Dividends

    Dec 02 | Clinical Research News | When the first all-civilian spaceflight, Inspiration4, was launched by SpaceX in 2021, it set into orbit the idea of future space habitation. It also marked the start of a long-term mission to understand the impact of the journey on everyday people without extensive astronaut training. More

  • Follow the Money: Hypertrophic Cardiomyopathy Therapeutic Candidate, Underserved Bleeding Disorders, Rare Disease Trials

    Nov 25 | Clinical Research News | Braveheart will advance their small molecule therapeutic candidate, BHB-1893, for hypertrophic cardiomyopathy; Hemab Therapeutics will keep developing sutacimig as the first-ever prophylactic treatment for Glanzmann thrombasthenia (GT); AAVantgarde will continue to work on their trials for treatments for Stargardt disease and Usher 1B; and more. More
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SOT

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior writer Deborah Borfitz welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.

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